Method and apparatus for stabilizing, straightening, expanding and/or flattening the side wall of a body lumen and/or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same

ABSTRACT

The present invention comprises the provision and use of a novel endoscopic device which is capable of stabilizing, straightening, expanding and/or flattening the side wall of a body lumen and/or body cavity so as to better present the side wall tissue for examination and/or treatment during an endoscopic procedure. The present invention also comprises the provision and use of a novel endoscopic device capable of steadying and/or stabilizing the distal tips and/or working ends of instruments inserted into a body lumen and/or body cavity, whereby to facilitate the use of those instruments.

REFERENCE TO PENDING PRIOR PATENT APPLICATION

This patent application is a continuation of pending prior U.S. patentapplication Ser. No. 14/540,355, filed Nov. 13, 2014 by CornellUniversity for METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING,EXPANDING AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN AND/OR BODYCAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/ORINCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTSRELATIVE TO THE SAME, which in turn is a continuation of prior U.S.patent application Ser. No. 12/969,059, filed Dec. 15, 2010 by JeffreyMilsom et al. for METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING,EXPANDING AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN AND/OR BODYCAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/ORINCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTSRELATIVE TO THE SAME, which claims benefit of prior U.S. ProvisionalPatent Application Ser. No. 61/284,215, filed Dec. 15, 2009 by JeffreyMilsom et al. for METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING,EXPANDING AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITYSO AS TO PROVIDE INCREASED VISUALIZATION OF THE SIDE WALL OF THE BODYLUMEN OR BODY CAVITY, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THESAME.

The three (3) above-identified patent applications are herebyincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to surgical methods and apparatus in general, andmore particularly to surgical methods and apparatus for stabilizing,straightening, expanding and/or flattening the side wall of a body lumenand/or body cavity so as to provide increased visualization of the sameand/or increased access to the same, and/or for stabilizing instrumentsrelative to the same.

BACKGROUND OF THE INVENTION

The human body comprises many different body lumens and body cavities.By way of example but not limitation, the human body comprises bodylumens such as the gastrointestinal (GI) tract, blood vessels, lymphaticvessels, the urinary tract, etc. By way of further example but notlimitation, the human body comprises body cavities such as the head,chest, abdomen, nasal sinuses, cavities within organs, etc.

In many cases it may be desirable to endoscopically examine and/or treata disease process or abnormality located within, or on the side wall of,a body lumen and/or body cavity. By way of example but not limitation,it may be desirable to examine the side wall of the gastrointestinaltract for lesions and, if a lesion is found, to biopsy, remove and/orotherwise treat the lesion.

The endoscopic examination and/or treatment of the side wall of a bodylumen and/or body cavity can be complicated by the geometry of the sidewall of the body lumen and/or body cavity, and/or by the consistency ofthe tissue making up the side wall of the body lumen and/or body cavity.By way of example but not limitation, the intestine is an elongatedorgan having an inner lumen characterized by frequent turns and a sidewall characterized by numerous folds, with the side wall tissue having arelatively soft, pliable consistency. It can be difficult to fullyvisualize the side wall of the intestine, and/or to treat a lesionformed on the side wall of the intestine, due to this varying side wallgeometry and its soft, pliable consistency. By way of example but notlimitation, in the case of colonoscopies, it has been found thatapproximately 5-30% of patients have a tissue geometry and/or a tissueconsistency which makes it difficult to fully visualize the anatomyusing conventional endoscopes, and/or to fully access the anatomy usinginstruments introduced through conventional endoscopes.

In addition to the foregoing, it has also been found that some bodylumens and/or body cavities can spasm and/or contract when an endoscopeis inserted into the body lumen and/or body cavity. This spasming and/orcontraction can cause the body lumen and/or body cavity to constrictand/or otherwise move and/or change its configuration, which can furthercomplicate and/or compromise endoscopic visualization of the anatomy,and/or further complicate and/or compromise access to the anatomy usinginstruments introduced through conventional endoscopes.

Since the ability of medical personnel to directly examine innersurfaces of the body is constantly increasing with the improvement andexpansion of new endoscopic devices, it would, therefore, be highlyadvantageous to provide an endoscopic device capable of stabilizing,straightening, expanding and/or flattening the side wall of a body lumenand/or body cavity so as to better present the side wall tissue forexamination and/or treatment during an endoscopic procedure.

It would also be highly advantageous to provide an endoscopic devicecapable of steadying and/or stabilizing the distal tips and/or workingends of instruments inserted into a body lumen and/or body cavity,whereby to facilitate the use of those instruments.

SUMMARY OF THE INVENTION

The present invention comprises the provision and use of a novelendoscopic device which is capable of stabilizing, straightening,expanding and/or flattening the side wall of a body lumen and/or bodycavity so as to better present the side wall tissue for examinationand/or treatment during an endoscopic procedure.

The present invention also comprises the provision and use of a novelendoscopic device capable of steadying and/or stabilizing the distaltips and/or working ends of instruments inserted into a body lumenand/or body cavity, whereby to facilitate the use of those instruments.

In one form of the present invention, there is provided apparatuscomprising:

a sleeve adapted to be slid over the exterior of an endoscope;

a proximal balloon secured to the sleeve near the distal end of thesleeve;

a pusher tube slidably mounted to the sleeve, the pusher tube beingconfigured to slidably receive a guidewire therein; and

a distal balloon secured to the distal end of the pusher tube.

In another form of the present invention, there is provided apparatuscomprising:

a sleeve adapted to be slid over the exterior of an endoscope;

a proximal balloon secured to the sleeve near the distal end of thesleeve;

a pusher element slidably mounted to the sleeve;

a double pull mechanism mounted to the sleeve for moving the pusherelement relative to the sleeve; and

a distal balloon secured to the distal end of the pusher element.

In another form of the present invention, there is provided apparatuscomprising:

a sleeve adapted to be slid over the exterior of an endoscope;

a proximal balloon secured to the sleeve near the distal end of thesleeve;

a pusher element slidably mounted to the sleeve, the pusher elementbeing substantially flexible, having substantial column strength, andhaving a length substantially shorter than the sleeve; and

a distal balloon secured to the distal end of the pusher element.

In another form of the present invention, there is provided a method forperforming a procedure in a body lumen and/or body cavity, the methodcomprising:

providing apparatus comprising:

-   -   a sleeve adapted to be slid over the exterior of an endoscope;    -   a proximal balloon secured to the sleeve near the distal end of        the sleeve;    -   a pusher tube slidably mounted to the sleeve, the pusher tube        being configured to slidably receive a guidewire therein; and    -   a distal balloon secured to the distal end of the pusher tube;

positioning the apparatus in the body lumen and/or body cavity;

inflating the proximal balloon;

advancing a guidewire through the pusher tube;

advancing the pusher tube along the guidewire;

inflating the distal balloon; and

performing the procedure.

In another form of the present invention, there is provided a method forperforming a procedure in a body lumen and/or body cavity, the methodcomprising:

providing apparatus comprising:

-   -   a sleeve adapted to be slid over the exterior of an endoscope;    -   a proximal balloon secured to the sleeve near the distal end of        the sleeve;    -   a pusher element slidably mounted to the sleeve;    -   a double pull mechanism mounted to the sleeve for moving the        pusher element relative to the sleeve; and    -   a distal balloon secured to the distal end of the pusher tube;

positioning the apparatus in the body lumen and/or body cavity;

inflating the proximal balloon;

advancing the pusher element distally relative to the sleeve;

inflating the distal balloon; and

performing the procedure.

In another form of the present invention, there is provided a method forperforming a procedure in a body lumen and/or body cavity, the methodcomprising:

providing apparatus comprising:

-   -   a sleeve adapted to be slid over the exterior of an endoscope;    -   a proximal balloon secured to the sleeve near the distal end of        the sleeve;    -   a pusher element slidably mounted to the sleeve, the pusher        element being substantially flexible, having substantial column        strength, and having a length substantially shorter than the        sleeve; and    -   a distal balloon secured to the distal end of the pusher        element;

positioning the apparatus in the body lumen and/or body cavity;

inflating the proximal balloon;

advancing the pusher element distally relative to the sleeve;

inflating the distal balloon; and

performing the procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts and further wherein:

FIG. 1 is a schematic side view showing a novel endoscopic stabilizingplatform formed in accordance with the present invention, wherein theendoscopic stabilizing platform is shown mounted on an endoscope anddeployed in a body lumen so as to stabilize, straighten, expand and/orflatten the side wall of the body lumen in order to provide increasedvisualization of the same and/or to provide increased stability for thedistal tips and/or working ends of instruments inserted into the bodylumen;

FIGS. 2-6, 6A and 7-12 are schematic views showing further details ofthe endoscopic stabilizing platform shown in FIG. 1;

FIGS. 13-15 are schematic views showing a controller for operating theendoscopic stabilizing platform of the present invention, and furtheraspects of the present invention, including a motorized drive system foruse in conjunction with the endoscopic stabilizing platform of thepresent invention;

FIG. 16 is a schematic view showing how radiopaque markers may beincorporated into and/or onto one or both of the balloons of theendoscopic stabilizing platform of the present invention;

FIGS. 17-33 are schematic views illustrating a preferred method of usingthe present invention; and

FIGS. 34-38 are schematic views showing an additional preferred methodof using the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The Novel EndoscopicStabilizing Platform

The present invention comprises the provision and use of a novelendoscopic stabilizing platform for stabilizing, straightening,expanding and/or flattening the side wall of a body lumen and/or bodycavity so as to better present the side wall tissue for examinationand/or treatment during an endoscopic procedure, and/or for stabilizinginstruments relative to the same. By way of example but not limitation,the novel endoscopic stabilizing platform can be used to stabilize,straighten, expand and/or flatten bends and/or curves and/or folds inthe side wall of a body lumen and/or body cavity so as to better presentthe side wall tissue for examination and/or treatment during anendoscopic procedure, and can provide a stable platform for theperformance of numerous procedures within the body lumen and/or bodycavity, including the stabilization of an endoscope and/or othersurgical instruments within the body lumen and/or body cavity, e.g.,during a lesion biopsy and/or lesion removal procedure, an organresection procedure, etc.

As used herein, the term “endoscopic procedure” is intended to meansubstantially any minimally-invasive or limited access procedure,diagnostic and/or surgical, for accessing the interior of a body lumenand/or body cavity for the purposes of viewing, biopsying and/ortreating tissue, including removing a lesion and/or resecting tissue,etc.

In accordance with the present invention, and looking now at FIG. 1,there is shown an endoscopic stabilizing platform 5 capable ofstabilizing, straightening, expanding and/or flattening the side wall ofa body lumen and/or body cavity so as to better present the side walltissue for examination and/or treatment during an endoscopic procedureusing an endoscope 10, and/or for stabilizing the distal tips and/orworking ends of instruments (not shown in FIG. 1) relative to the same.

More particularly, endoscopic stabilizing platform 5 generally comprisesa sleeve 15 adapted to be slid over the exterior of the shaft ofendoscope 10 as will hereinafter be discussed, a proximal (or “aft”)balloon 20 secured to sleeve 15 near the distal end of the sleeve, and ahandle 25 secured to sleeve 15 at the proximal end of the sleeve.Endoscopic stabilizing platform 5 also comprises a pusher tube 30slidably mounted to sleeve 15 as will hereinafter be discussed, and adistal (or “fore”) balloon 35 secured to the distal end of pusher tube30, whereby the spacing between proximal balloon 20 and distal balloon35 can be adjusted by the surgeon during use by moving pusher tube 30relative to sleeve 15. Endoscopic stabilizing platform 5 also comprisesa hand piece 40 for enabling operation of endoscopic stabilizingplatform 5 by a surgeon.

Looking next at FIGS. 1-6 and 6A, sleeve 15 generally comprises anelongated, thin-walled tube configured to be slid over the exterior ofthe shaft of endoscope 10 so as to make a close fit therewith, such thatthe sleeve will slide easily over the endoscope during mounting but willhave sufficient residual friction with the outer surface of theendoscope that the sleeve will remain in place during use. Sleeve 15 issized so that when its distal end is substantially aligned with thedistal end of endoscope 10, sleeve 15 (and handle 25) will substantiallycover the shaft of the endoscope. Sleeve 15 preferably has a smoothouter surface so as to be non-traumatic to tissue, and is preferablymade of a highly flexible material such that the sleeve will not inhibitbending of the endoscope during use. In one preferred form of theinvention, sleeve 15 comprises polyethylene. If desired, sleeve 15 caninclude a lubricious coating on some or all of its interior and/orexterior surfaces, so as to facilitate disposition of the sleeve overthe endoscope and/or movement of endoscopic stabilizing platform 5through a body lumen and/or body cavity, respectively.

Proximal (or “aft”) balloon 20 is secured to sleeve 15 near the distalend of the sleeve. Proximal balloon 20 is disposed concentrically aboutsleeve 15, and hence concentrically about endoscope 10 disposed withinsleeve 15. Proximal balloon 20 may be selectively inflated/deflated bymeans of a proximal inflation/deflation tube 45 which is secured to theexterior surface of sleeve 15, whereby proximal balloon 20 may beselectively secured to/released from the adjacent anatomy, respectively,as will hereinafter be discussed. Preferably proximal balloon 20 isdisposed a short distance back from the distal end of sleeve 15, i.e.,by a distance which is approximately the same as the length of theflexible portion of an endoscope, so that the flexible portion of anendoscope will be disposed distal to the proximal balloon 20 when theendoscope is disposed in sleeve 15. This construction allows theflexible portion of the endoscope to be articulated even when proximalballoon 20 has been inflated in the anatomy so as to stabilize theadjacent non-articulating portion of the endoscope relative to theanatomy, as will hereinafter be discussed in further detail.

Handle 25 is secured to the proximal end of sleeve 15. Handle 25preferably comprises a substantially rigid or semi-rigid structure whichmay be gripped by the hand of the surgeon and pulled proximally so as topull sleeve 15 over the exterior surface of endoscope 10, whereby tomount sleeve 15 to the shaft of the endoscope.

Pusher tube 30 is slidably mounted to sleeve 15, whereby the distal endof the pusher tube can be extended and/or retracted relative to sleeve15, and hence extended and/or retracted relative to the distal end ofendoscope 10 disposed in sleeve 15.

More particularly, pusher tube 30 is a relatively short element which isslidably disposed in a support tube 50 which is secured to the outersurface of sheath 15. Pusher tube 30 is preferably formed out of arelatively flexible material which provides good column strength, e.g.,a superelastic material such as a shape memory alloy. By way of examplebut not limitation, pusher tube 30 may be formed out of Nitinol. Adouble pull line 55 is secured to the outer surface of pusher tube 30,e.g., by wrapping the double pull line around the outer surface of theproximal end of pusher tube 30 and gluing it in place (FIG. 6). Doublepull line 55 has a retract line 60 which extends proximally throughsupport tube 50 and then crosses over to a retract tube 63. The proximalend of retract line 60 exits retract tube 63 adjacent the proximal endof sleeve 15, e.g., near handle 25. Double pull line 55 also has anextend line 65 which extends distally through support tube 50, around a“pulley” (i.e., bearing structure) 70 (FIG. 5) disposed at the distalend of support tube 50, and then back through an extend tube 75 which issecured to the outer surface of sleeve 15. The proximal end of extendline 65 exits extend tube 75 adjacent the proximal end of sleeve 15,e.g., near handle 15. As a result of this construction, pulling theproximal end of retract line 60 proximally causes the distal end ofpusher tube 30 to retract proximally relative to sleeve 15, and pullingthe proximal end of extend line 65 proximally causes the distal end ofpusher tube 30 to extend distally relative to sleeve 15.

Thus it will be seen that a pulling motion, selectively applied toretract line 60 or extend line 65, is used for both retracting andextending pusher tube 30 relative to sleeve 15 (and hence relative to anendoscope 10 disposed in sleeve 15). Furthermore, this pulling motion isapplied to the relatively short pusher tube 30 fairly close to thedistal end of sleeve 15, and the pusher tube is constructed so as tohave a relatively high column strength along its length. As a result,this construction permits a substantial extension force to be applied tothe distal end of pusher tube 30, which can be important when traversinga tortuous body lumen deep within the anatomy of a patient, as willhereinafter be discussed. At the same time, since retract line 60 andextend line 65 act in tension, they can be highly flexible, and sincepusher tube 30 is relatively short and does not need to extend for theentire length of sleeve 15, pusher tube 30 can be relatively flexibleeven as it delivers good column strength. As a result, endoscopicstabilizing platform 5 is highly flexible along its length, even as itpermits a substantial extension force to be applied to the distal end ofpusher tube 30. This is a substantial advance in the art since, in theabsence of such a construction, a long pusher tube, having substantialcolumn strength along its entire length, would have to be used totransfer a substantial extension force from the proximal end of theendoscopic stabilizing platform to the distal end of the endoscopicstabilizing platform. But such a long pusher tube, with substantialcolumn strength along its entire length, would undermine the desiredflexibility of the endoscopic stabilizing platform.

Thus, as a result of its unique construction, endoscopic stabilizingplatform 5 can extend a substantial length into the body, be highlyflexible so as to traverse a highly tortuous body lumen (e.g., the GItract), and still generate a substantial distally-directed force topusher tube 30.

Pusher tube 30 includes an internal lumen 80 which is sized toaccommodate a guidewire 85 therein, which permits pusher tube 30, andhence distal balloon 35 secured to the distal end of pusher tube 30, tobe directed by a guidewire 85, as will hereinafter be discussed infurther detail. The proximal end of guidewire 85 extends throughguidewire tube 87, which is secured to the outer surface of sleeve 15.The proximal end of guidewire 85 exits guidewire tube 87 adjacent theproximal end of sleeve 15, e.g., near handle 25.

Distal (or “fore”) balloon 35 is secured to the distal end of pushertube 30, whereby the spacing between proximal (or “aft”) balloon 20 anddistal (or “fore”) balloon 35 can be adjusted by moving pusher tube 30relative to sleeve 15. Distal balloon 35 is disposed concentricallyabout pusher tube 30, and hence concentrically about guidewire 85disposed within pusher tube 30. Distal balloon 35 may be selectivelyinflated/deflated by means of a distal inflation/deflation tube 90 whichis secured to the exterior surface of sleeve 15, whereby distal balloon35 may be selectively secured to/released from the adjacent anatomy,respectively. However, the distal end of inflation/deflation tube 90 isnot secured to the exterior surface of sleeve 15, and is preferablyrelatively flexible, so that inflation/deflation tube 90 can accommodatemovement of pusher tune 30 (and hence distal balloon 35) relative tosleeve 15.

Preferably, and looking now at FIGS. 6 and 7, a rip sleeve 95 isinitially disposed over the deflated proximal balloon 20 and distalballoon 35 so as to facilitate “snag-free” insertion of endoscopicstabilizing platform 5 into and through a body lumen and/or body cavity.When the distal end of endoscopic stabilizing platform 5 has beenadvanced to the location of use, rip sleeve 95 can be removed by pullingon the proximal end of a rip cord 100, which extends along a rip cordtube 105 which is secured to the outer surface of sleeve 15, whereby tofree proximal balloon 20 and distal balloon 35 for subsequent inflation,e.g., in the manner shown in FIG. 8. In this respect it will beappreciated that the proximal end of rip cord 100 exits rip cord tube105 adjacent the proximal end of sleeve 15, e.g., near handle 25.

Preferably, an overlay sleeve 110 is disposed over exterior surfaces ofproximal inflation/deflation tube 45, support tube 50, retract tube 63,extend tube 75, guidewire tube 87, inflation/deflation tube 90 and ripcord tube 105. In one form of the invention, overlay sleeve 110 extendsabout the entire circumference of sleeve 15 for a portion of thedistance between proximal balloon 20 and handle 25. Overlay sleeve 110helps ensure that the outer surface of endoscopic stabilizing platform 5is smooth and “snag-free” so that the endoscopic stabilizing platformcan move easily within a body lumen and/or body cavity, without causingsignificant trauma to the tissue. If desired, overlay sleeve 110 caninclude a lubricious coating on some or all of its exterior surface soas to facilitate movement of endoscopic stabilizing platform 5 through abody lumen and/or body cavity.

Hand piece 40 is shown in FIGS. 1, 2 and 9-12. Hand piece 40 enablessingle-handed operation of endoscopic stabilizing platform 5 by asurgeon who is simultaneously manipulating endoscope 10. Moreparticularly, hand piece 40 comprises a collar 115 which is adapted tomount over endoscope 10. Collar 115 is configured to be slid over theexterior of the shaft of endoscope 10 so as to make a close fittherewith, such that the collar will slide easily over the endoscopeduring mounting but will have sufficient residual friction with theouter surface of the endoscope that the hand piece will remain in placeduring use. Hand piece 40 also comprises an arm 120 which providescontrols for advancing/retracting pusher tube 30 relative to sleeve 15,inflating/deflating proximal balloon 20, and/or inflating/deflatingdistal balloon 35, as will hereinafter be discussed in further detail.Note that arm 120 is configured so as to place the aforementionedcontrols immediately adjacent to the endoscope controls, whereby topermit easy one-hand operation by the surgeon.

Hand piece 40 is preferably configured to operate in conjunction with acontroller 125 (FIG. 13), with hand piece 40 providing the means bywhich the surgeon controls operation of controller 125. Controller 125is adapted to supply/withdraw fluid (e.g., air, saline, etc.) to/fromproximal balloon 20 and/or distal balloon 35, whereby to selectivelyinflate/deflate one or the other, or both, of the balloons. Controller125 is also adapted to control operation of a motorized drive system 130(FIGS. 13 and 14) which is adapted to (i) selectively apply a pullingforce to the proximal end of retract line 60, whereby to retract pushertube 30 relative to sleeve 15, (ii) selectively apply a pulling force tothe proximal end of extend line 65, whereby to extend pusher tube 30relative to sleeve 15, or (iii) not apply a pulling force to eitherretract line 60 or extend line 65. The ability of motorized drive system130 to not apply a pulling force to either retract line 60 or extendline 65 is an important aspect of the present invention, since it meansthat motorized drive system 130 can hold pusher tube 30 (and hencedistal balloon 35) in a fixed position relative to sleeve 15 (and henceendoscope 10), which can be extremely important in stabilizing endoscopestabilizing platform 5 relative to the anatomy.

To this end, motorized drive system 130 preferably comprises a retractpull pin 135 and an extend pull pin 140 which are adapted to beselectively moved relative to a base 145. Retract pull pin 135 isadapted to receive an eyelet 150 (FIG. 15) formed at the proximal end ofretract line 60, and extend pull pin 140 is adapted to receive an eyelet155 formed at the proximal end of extend line 65. Preferably, a cassette160 (FIG. 15) provides support for retract line 60 and extend line 65,with cassette 160 being received on cassette locating pins 165 disposedon motorized drive system 130.

On account of the foregoing arrangements, a surgeon can use the controlson hand piece 40 to cause controller 125 to selectively inflate/deflateproximal balloon 20, and/or inflate/deflate distal balloon 35.Furthermore, a surgeon can use the controls on hand piece 40 to causecontroller 125 to selectively (i) retract pusher tube 30 relative tosleeve 15, (ii) extend pusher tube 30 relative to sleeve 15, or (iii)hold pusher tube 30 stationary relative to sleeve 15.

If desired, one or both of proximal balloon 20 and distal balloon 35 mayinclude radiopaque markers 170 thereon, whereby to facilitatevisualization of balloon location under X-ray or fluoroscopic viewing.

Furthermore, if desired, means can be provided (e.g., at controller 125)to monitor the pressure within proximal balloon 20 and distal balloon35, whereby to prevent balloon rupture and/or the application ofexcessive balloon pressure against the adjacent anatomy, both of whichcould cause trauma to the anatomy. Such means will be obvious to aperson of ordinary skill in the art in view of the present disclosure.

And, if desired, means could be provided (e.g., at controller 125 and/ormotorized drive system 130) to limit the distal extension force appliedto pusher tube 30, again to avoid trauma to the anatomy. Such means willbe obvious to a person of ordinary skill in the art in view of thepresent disclosure.

Significantly, all of endoscopic stabilizing platform 5, with thepossible exception of hand piece 40 (and, of course related controller125 and the related motorized drive system 130) may be disposed of atthe conclusion of a procedure.

Preferred Method of Using the Novel Endoscopic Stabilizing Platform

Endoscopic stabilizing platform 5 may be used to stabilize, straighten,expand and/or flatten the side wall of a body lumen and/or body cavityso as to better present the side wall tissue for examination and/ortreatment during an endoscopic procedure using endoscope 10, and/or tostabilize the distal tips and/or working ends of instruments relative tothe same.

More particularly, in use, hand piece 40 is first mounted to endoscope10 (FIG. 17), e.g., by pulling collar 115 over the shaft of theendoscope. Next, sleeve 15 is mounted to endoscope 10, i.e., by pullinghandle 25 proximally onto the shaft of endoscope 10 (FIG. 18). Then,hand piece 40 has its electrical and fluid connections connected tocontroller 125 (FIG. 19), and retract line 60 and extend line 65 areconnected to motorized drive system 130, e.g., by mounting eyelet 150 ofretract line 60 on retract pull pin 135 and mounting eyelet 155 ofextend line 65 on extend pull pin 140 (FIGS. 13-15). Next guidewire 85is advanced through guidewire tube 87 and into support tube 30 until thedistal tip of the guidewire is adjacent to the distal tip of endoscope10 (FIG. 20). At this point, endoscope 10 and endoscopic stabilizingplatform 5 are ready for insertion as a unit into the patent.

Looking next at FIG. 21, endoscope 10 and endoscopic stabilizingplatform 5 are inserted as a unit into a body lumen and/or body cavityof the patient. By way of example but not limitation, endoscope 10 andendoscopic stabilizing platform 5 are inserted as a unit into thegastrointestinal (GI) tract of the patient. Endoscope 10 and endoscopicstabilizing platform 5 are advanced along the body lumen and/or bodycavity to a desired location within the patient (FIGS. 22 and 23).

When endoscopic stabilizing platform 5 is to be used, rip cord 100 ispulled proximally so as to tear away rip sleeve 95 (FIG. 24). Thenproximal balloon 20 is inflated so as to stabilize the endoscopicstabilizing platform (and hence endoscope 10) within the body lumenand/or body cavity.

Next, guidewire 85 is advanced a further distance into the body lumenand/or body cavity (FIG. 25). In this respect it will be appreciatedthat the relatively small and relatively easily-steerable guidewire 85will be relatively easy to direct to a desired location further down thebody lumen and/or body passageway, particularly inasmuch as theguidewire may be advanced some or all of the way under directvisualization from endoscope 10. In this respect it will also beappreciated that inasmuch as the flexible portion of the endoscoperesides distal to proximal balloon 20, the endoscope will be able toarticulate distal to the balloon so as to facilitate visualization ofthe anatomy.

Next, pusher tube 30 is advanced distally along the guidewire (FIG. 26).Thus, guidewire 85 acts as guide for moving pusher tube 30, and hencedistal balloon 35, distally relative to the endoscope 10.

When pusher tube 30 has advanced distal balloon 35 to the desiredposition along guidewire 85, distal balloon 35 is inflated (FIG. 27) soas to secure distal balloon 35 to the anatomy. As distal balloon 35 isinflated, the inflated distal balloon 35 and the inflated proximalballoon 20 will cooperate with one another so as to stabilize,straighten, expand and/or flatten the side wall of the body lumen and/orbody cavity so as to better present the side wall tissue for examinationand/or treatment during an endoscopic procedure using endoscope 10. Inthis respect it will be appreciated that the inflated distal balloon 35and the inflated proximal balloon 20 will together expand and tensionthe side wall of the body lumen and/or body cavity, and pusher tube 30will tend to straighten the anatomy between the two inflated balloons.In this respect it will also be appreciated that once proximal balloon20 and distal balloon 30 have both been inflated, they will togetherdefine a substantially closed region along the body lumen and/or bodycavity (i.e., an isolated therapeutic zone) which can then be inflatedwith a fluid (e.g., air, CO₂, etc.). This fluid can significantlyenhance visualization of the side wall of the body lumen and/or bodycavity.

If desired, distal balloon 35 can be retracted toward proximal balloon20, while remaining inflated, so as to move the anatomy and furtherimprove visualization (see FIG. 28).

If desired, surgical tools 175 (FIG. 29) may be advanced throughendoscope 10 so as to biopsy and/or treat the anatomy. It will beappreciated that such instruments will be advanced out of the distal endof the endoscope, which is highly stabilized relative to the anatomy viaproximal balloon 20, so that the working ends of instruments 175 willalso be highly stabilized relative to the anatomy. This is a significantadvantage over the prior art practice of advancing tools out of thenon-stabilized end of an endoscope.

Furthermore, if bleeding were to obscure a tissue site, the isolatedtherapeutic zone permits rapid flushing of the anatomy and subsequentremoval of the flushing liquid (see FIGS. 30-32).

Also, if desired, the distal balloon 35 can be directed with highprecision to the bleeding site via guidewire 85 and theguidewire-tracking pusher tube 30, whereupon distal balloon 35 may beused to apply topical pressure to the bleeding site in order to enhancebleeding control (see FIG. 33). This can be done under the visualizationprovided by endoscope 10.

If desired, the distal balloon 35 may be used as a drag brake to controlendoscope removal. More particularly, in this form of the invention, theendoscope 10 and the endoscopic stabilizing platform 5 are firstadvanced as a unit into the body lumen and/or body cavity until the tipof the endoscope is at the proper location, and then guidewire 85 isadvanced distally. Next, proximal balloon 20 is inflated, pusher tube 30is advanced distally along guidewire 85, and distal balloon 35 isinflated (FIG. 35). When the apparatus is to be withdrawn, proximalballoon 20 is deflated, distal balloon 35 is partially deflated, andthen the endoscope is withdrawn proximally, dragging the semi-inflateddistal balloon 35 along (FIG. 36), with distal balloon 35 acting assomething of a brake as the endoscope is pulled proximally, therebyenabling a more controlled withdrawal of the endoscope and hence bettervisualization of the anatomy. If at some point it is desired, proximalballoon 20 and distal balloon 35 can be re-inflated, as shown in FIG.37, with or without introduction of a fluid into the “isolatedtherapeutic zone” established between the two balloons, so as tostabilize, straighten, expand and/or flatten the anatomy. At theconclusion of the procedures, the system is withdrawn from the anatomy(FIG. 38).

It is also possible to use proximal balloon 20 as a brake whenwithdrawing the endoscope (and hence endoscopic stabilizing platform 5)from the anatomy, either alone or in combination with braking actionfrom distal balloon 35.

APPLICATIONS

The novel endoscopic stabilizing platform of the present invention canbe used in substantially any endoscopic procedure to facilitate thealignment and presentation of tissue during an endoscopic procedureand/or to, stabilize the working end of an endoscope (and/or otherinstruments advanced through the endoscope) relative to tissue duringsuch a procedure.

The present invention is believed to have widest applications withrespect to the gastrointestinal (GI) tract (e.g., large and smallintestines, esophagus, stomach, etc.), which is generally characterizedby frequent turns and which has a side wall characterized by numerousfolds and disease processes located within these folds. However, themethods and apparatus of the present invention may also be used insideother body cavities (e.g., the cranium, thorax, abdomen, pelvis, nasalsinuses, bladder, etc.) and/or other tubular viscera (e.g., the vagina,ureter, fallopian tubes, urethra, blood vessels, bronchi, bile ducts,etc.).

Thus, for example, the novel endoscopic stabilizing platform of thepresent invention can be used in the performance of certain specializedendoscopic procedures including Natural Orifice Trans-Endoscopic Surgery(NOTES) procedures, as well as other complex endoscopic procedures whichcould involve endoscopic surgery.

MODIFICATIONS

While the present invention has been described in terms of certainexemplary preferred embodiments, it will be readily understood andappreciated by one of ordinary skill in the art that it is not solimited, and that many additions, deletions and modifications may bemade to the preferred embodiments discussed above while remaining withinthe scope of the present invention.

What is claimed is:
 1. A method for providing increased access to theside wall of a body lumen and/or body cavity while using an endoscope tovisualize the side wall of the body lumen and/or body cavity, theendoscope having a distal end and a proximal end, wherein the proximalend of the endoscope comprises a handle, the method comprising:providing an apparatus comprising: a sleeve comprising a distal end, aproximal end and a lumen extending therebetween, the lumen being sizedto receive the endoscope therein, and the sleeve being sized to extendover the endoscope from a location adjacent to the distal end of theendoscope to a location adjacent to the handle of the endoscope, whereinthe sleeve comprises a channel having a distal end and a proximal end,wherein the distal end of the channel is disposed adjacent to the distalend of the sleeve and the proximal end of the channel is disposedadjacent to the proximal end of the sleeve; a proximal balloon securedto the sleeve near the distal end of the sleeve; a pusher tube slidablydisposed in the channel of the sleeve so as to be movable relative tothe sleeve, wherein the pusher tube comprises a distal end and aproximal end, with the distal end of the pusher tube being configured toextend out of the distal end of the channel, and with the proximal endof the pusher tube being configured to extend out the proximal end ofthe channel; and a distal balloon secured to the distal end of thepusher tube; sliding the sleeve over the endoscope so that the endoscopeis disposed in the lumen of the sleeve and so that the distal end of thesleeve is disposed adjacent to the distal end of the endoscope and theproximal end of the sleeve is disposed adjacent to the handle of theendoscope; positioning the endoscope and the apparatus in the body lumenand/or body cavity; inflating the proximal balloon; advancing the pushertube relative to the sleeve so as to advance the distal balloon relativeto the proximal balloon; inflating the distal balloon so as to create asubstantially fluidically sealed zone between the proximal balloon andthe distal balloon; and introducing fluid into the substantiallyfluidically sealed zone between the proximal balloon and the distalballoon.
 2. A method according to claim 1 wherein the fluid introducedinto the substantially fluidically sealed zone comprises air.
 3. Amethod according to claim 1 wherein the fluid introduced into thesubstantially fluidically sealed zone comprises CO₂.
 4. A methodaccording to claim 1 wherein the fluid introduced into the substantiallyfluidically sealed zone comprises flushing liquid.
 5. A method accordingto claim 4 further comprising removing flushing liquid from thesubstantially fluidically sealed zone.
 6. A method according to claim 1further comprising advancing a tool through the endoscope to thesubstantially fluidically sealed zone.
 7. A method according to claim 6further comprising using the tool to perform a procedure within thesubstantially fluidically sealed zone.
 8. A method according to claim 7wherein the procedure comprises a biopsy.